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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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The overall objective is to compare the effect of Vancomycin and Tobramycin powder combined (treatment) to Vancomycin powder (control) in the reduction of post-fixation infections of tibial plateau and tibial pilon fractures at high risk of infection (collectively considered the "study injuries").
Specific Aim 1: Compare the proportion of deep surgical site infections (SSI) of the study injury within 182 days of definitive fracture fixation surgery in patients allocated to receive a combination of local Vancomycin and Tobramycin powders compared to patients allocated to local Vancomycin powder.
Sensitivity Analyses: A series of sensitivity analyses will be conducted to look at alternative measures of deep SSI under Specific Aim 1. These sensitivity analyses will consider the following alternative end points of deep SSI: infection by only gram-negative bacteria, infection by any gram-positive bacteria (with or without other organisms of any type), polymicrobial pathogenic infections, culture negative infections, and cellulitis/skin infections.
Specific Aim 2: To compare the safety of treatment with a combination of local Vancomycin and Tobramycin versus Vancomycin powder alone as measured by the proportion of antibiotic resistance in each arm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Standard of Care + Local Vancomycin: Participants in the control group will receive a dose of 1000mg of Vancomycin powder in their wound bed, which is placed right before wound closure at the final stage of definitive fracture fixation. |
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| Treatment | Experimental | Standard of Care + Local Vancomycin + Local Tobramycin: Participants in the treatment group will receive a dose of 1000mg of Vancomycin powder AND a dose of 1200mg of Tobramycin powder in their wound bed, which is placed right before wound closure at the final stafe of definitive fracture fixation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment group | Drug | Standard of Care + Local Vancomycin + Local Tobramycin: Participants in the treatment group will receive a dose of 1000mg of Vancomycin powder AND a dose of 1200mg of Tobramycin powder in their wound bed, which is placed right before wound closure at the final stafe of definitive fracture fixation. |
| Measure | Description | Time Frame |
|---|---|---|
| Deep Surgical Site Infection (SSI) | Compare the proportion of deep SSIs of the study injury within 182 days of definitive fracture fixation surgery in patients treated with local Vancomycin powder compared to those treated with a combination of local Vancomycin and Tobramycin powders. For this study a "deep SSI" is a SSI that is treated with operative debridement. In the current CDC terminology this would include all deep organ space, deep incisional, and superficial infections that are treated with surgery. | within 182 days of definitive fracture fixation surgery |
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Inclusion Criteria:
Tibial plateau or tibial pilon fractures that is treated operatively with plate and screw fixation AND at least one of the following characteristics indicative of higher risk of infection:
Patients ages 18 through 80 years.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert V O'Toole, MD, MS | University of Maryland, Department of Orthopaedic Trauma | Principal Investigator |
| Renan C Castillo, PhD | Johns Hopkins Bloomberg School of Public Health | Principal Investigator |
| Anthony R Carlini, MS | Johns Hopkins Bloomberg School of Public Health | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Heersink School of Medicine | Birmingham | Alabama | 35205 | United States | ||
| Keck School of Medicine of USC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40667718 | Derived | Schrank GM, O'Hara NN, Lee S, Degani Y, Chung S, Carlini AR, Castillo RC, O'Toole RV. Safety of topical tobramycin powder during operative treatment of fractures. J Antimicrob Chemother. 2025 Sep 3;80(9):2417-2420. doi: 10.1093/jac/dkaf230. |
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| Control group | Drug | Standard of Care + Local Vancomycin: Participants in the control group will receive a dose of 1000mg of Vancomycin powder in their wound bed, which is placed right before wound closure at the final stage of definitive fracture fixation. |
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| Los Angeles |
| California |
| 90033 |
| United States |
| Stanford University | Redwood City | California | 94063 | United States |
| _University of California, San Francisco | San Francisco | California | 94110 | United States |
| Cedars Sinai | West Hollywood | California | 90069 | United States |
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | United States |
| St Mary's University/Tenent Health | West Palm Beach | Florida | 33407 | United States |
| Loyola University Chicago | Chicago | Illinois | 60153 | United States |
| Indiana University School of Medicine - Methodist Hospital | Indianapolis | Indiana | 46202 | United States |
| Indiana University/Eskenazi Health | Indianapolis | Indiana | 46202 | United States |
| University of Kentucky | Lexington | Kentucky | 40506 | United States |
| LSU Health Sciences | New Orleans | Louisiana | 70112 | United States |
| University of Maryland Shock Trauma Center | Baltimore | Maryland | 21201 | United States |
| University of Maryland Shock Trauma/Capitol Regions | Baltimore | Maryland | 21201 | United States |
| Harvard/Mass General/Brigham Hospitals | Boston | Massachusetts | 02115 | United States |
| Core Well Health | Grand Rapids | Michigan | 49503 | United States |
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| Dartmouth Hitchcock | Lebanon | New Hampshire | 03766 | United States |
| New York Presbyterian/Hospital for Special Surgery | New York | New York | 10021 | United States |
| Jamaica Hospital Medical Center | Queens | New York | 11418 | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27514 | United States |
| Carolinas Medical Center/Atrium Health Musculoskeletal Health Institute | Charlotte | North Carolina | 28203 | United States |
| Atrium Health Wake Forest Baptist | Winston-Salem | North Carolina | 27157 | United States |
| METROHealth | Cleveland | Ohio | 44109 | United States |
| Ohio State University Wexner Medical Center | Columbus | Ohio | 43201 | United States |
| University of Oklahoma College of Medicine | Oklahoma City | Oklahoma | 73104 | United States |
| Penn State College of Medicine | Hershey | Pennsylvania | 17033 | United States |
| University of Pennsylvania Perelman School of Medicine | Philadelphia | Pennsylvania | 19106 | United States |
| Temple University | Philadelphia | Pennsylvania | 19140 | United States |
| Rhode Island Hospital/Brown University | Providence | Rhode Island | 02905 | United States |
| Medical University of South Carolina - | Charleston | South Carolina | 29425 | United States |
| Vanderbilt University | Nashville | Tennessee | 37232 | United States |
| Baylor Scott & White Research Institute | Dallas | Texas | 75246 | United States |
| UTHealth/McGovern Medical School | Houston | Texas | 77030 | United States |
| UT Health San Antonio | San Antonio | Texas | 78229 | United States |
| University of Utah | Salt Lake City | Utah | 84108 | United States |
| University of Virginia | Charlottesville | Virginia | 22903 | United States |
| Inova Fairfax MEdical Campus | Falls Church | Virginia | 22042 | United States |
| Virginia Commonwealth University Medical Center | Richmond | Virginia | 23298 | United States |
| University of Wisconsin | Madison | Wisconsin | 53705 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 27, 2026 | Jun 23, 2026 | 18 | ||
| Jun 23, 2026 |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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